Senior Specialist Process Excellence

Bristol-Myers Squibb Co; Boudry; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb in Switzerland is seeking a Senior Specialist Process Excellence Compliance to lead Quality Events management and support inspection readiness and regulatory audits. You will own quality events (CAPAs, change controls, complaints, deviations), maintain GMP documents, and ensure timely approvals through the document system.

The role requires a life sciences degree, 3–5 years GMP compliance experience, knowledge of regulatory requirements, and strong communication, analytical,

Qualifikationen

• Bachelor's degree in Life Sciences or related field.
• 3-5 years' experience in GMP compliance.
• Knowledge of regulatory requirements and audit processes.
• Experienced in Health Authority inspections and responses drafting.
• Knowledge of pharmaceutical facilities and OSd processes.
• Strong communication skills and cross-functional workability.
• Business level in French and English.

Aufgaben

• Own quality Event and associated actions (CAPAs, Change Controls, complaints and deviations).
• Author and maintain GMP documentation (SOPs, specifications, forms, logbooks).
• Manage approval flow within electronic document system and coordinate stakeholders.
• Contribute to inspection readiness and regulatory audits.
• Support root cause analysis.
• Contribute to quality KPI adherence.
• Perform and/or own impact assessments and risk evaluations.
• Drive local continuous improvement and site initiatives.
• Participate in compliance boards and forums.

Kenntnisse

Verbal communication

Written communication

Analytical thinking

Problem solving

Influencing

Deductive reasoning

Cross-functional collaboration

Ausbildung

Bachelor's degree in Life Sciences or related field

Jobbeschreibung

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Senior Specialist Process Excellence Compliance contributes to the PU compliance excellence through the management of Quality Events and contributions to inspection readiness and regulatory audits.

Duties/Responsibilities

• Own quality Event and associated actions (eg: CAPAs, Change Controls, complaints and deviations).
• Author and maintain GMP documentation (including SOP, specifications, working practices, Forms and logbooks).
• Follow up approval flow within electronic documentations system and facilitate all stakeholders input to ensure documents are updated and approved in a timely manner.
• Contribute to inspection readiness and regulatory audits.
• Support root cause analysis.
• Contribute to quality KPI adherence.
• Perform and/or own impact assessments and risk evaluations.
• Drive local continuous improvement and site initiatives.
• Participate in compliance boards and forums.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 3-5 years' experience in GMP compliance.
• Knowledge of regulatory requirements and audit processes.
• Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.).
• Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes especially in Oral Solid Dosage form (OSD).
• Well-developed ability to constructively work across functional areas and levels to achieve results.
• Strong verbal and written communication skills.
• Strong analytical, problem solving, influential and deductive skills.
• Capability to work with short deadlines and simultaneous activities.
• Excellent organizational and project management skills.
• Business Level in French and English.

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People with Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.